Large-Scale Biotronik SPIRIT-ICD Study Enrollment Complete

July 11, 2012 — Biotronik announced enrollment is now complete for the SPIRIT-ICD study, with 503 patients from 37 sites in 11 countries worldwide registered.

The SPIRIT-ICD study was initiated based on findings from the MADIT II trial, which showed that patients who received an appropriate therapy from an implantable cardioverter-defibrillator (ICD)that was implanted for primary prevention had a significantly increased risk for all-cause mortality. SPIRIT-ICD is a prospective, uncontrolled, multicenter trial to investigate whether this high-risk group might benefit from an intensified diagnostic follow-up and timely therapeutic intervention.

Study patients will be closely monitored for at least one year after enrollment via Biotronik Home Monitoring, a globally accessible, Internet-based, automatic remote monitoring system that uniquely enables physicians to follow their patients’ clinical status and device status no matter where they are.

If an appropriate therapy (shock or antitachycardia pacing [ATP]) is delivered, the study protocol requires a hospital visit within 72 hours to undergo intensified diagnostics and, at the investigator’s discretion, to receive state-of-the-art therapeutic interventions. If an appropriate therapy is delivered during the patient’s observation period, monitoring is to be extended for an additional 12 months after the event.

Further parameters to be compared and analyzed between the groups are sudden cardiac death, nonsudden cardiac death, risk of first heart failure hospitalization, number of ventricular tachycardia (VT) storms and number of delivered ICD therapies. In addition, the large study sample of the SPIRIT-ICD study allows for conclusions to be drawn on the current standard of care as compared to the findings of the MADIT II trial. Final results of the SPIRIT-ICD study are expected in early 2015.

The MADIT II trial was the first study of its kind to examine survival benefits of ICD implantation in patients with a history of myocardial infarction and left ventricular dysfunction.